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The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.
Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses.
Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms.
Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents.
In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement.
The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety.
With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.
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| Measure | Description | Time Frame |
|---|---|---|
| Subject's Average Time Spent on Cardiopulmonary Cross Clamp | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. | At time of surgery; an average of 1 hour |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject's Average Time Spent on Cardiopulmonary Bypass | Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. | At time of surgery; an average of 1.5 hours |
| Subject's Average Skin-to-skin Time |
Inclusion Criteria:
Exclusion Criteria:
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Adult subjects, age 18 or older, that have been diagnosed with aortic stenosis or stenosis-based insufficiency and are scheduled to undergo surgical aortic valve replacement are eligible for participation in this study. Study subjects shall be drawn from the general patient populations served by each investigational center. Candidates for this study must meet all of the following inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Glauber, MD | Organizational Affiliation: OSPEDALE "G. PASQUINUCCI" CREAS IFC-CNR | Principal Investigator |
| Prof.Christopher Young, MD FRCS | Guy's & St Thomas' Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salzburger Universitätsklinikum | Salzburg | 5020 | Austria | |||
| Landesklinikum - St. Pölten |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29415382 | Result | Young C, Laufer G, Kocher A, Solinas M, Alamanni F, Polvani G, Podesser BK, Aramendi JI, Arribas J, Bouchot O, Livi U, Massetti M, Terp K, Giot C, Glauber M. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Feb;155(2):575-585. doi: 10.1016/j.jtcvs.2017.09.133. Epub 2017 Oct 31. |
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516 Subjects were enrolled in this study, for which data is available.
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| ID | Title | Description |
|---|---|---|
| FG000 | EDWARDS INTUITY Aortic Valve | Aortic valve replacement therapy Heart Valve Surgery: The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The time from start of skin incision to end of skin closure. |
| At time of surgery; an average of 3.5 hours |
| Subject's Device Technical Success | Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place. | At time of surgery |
| Subject's Average Health Care Utilization | The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure. | Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively. |
| Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | 30 days, 3 months, 1 year, 2 years |
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | Baseline, 3 months |
| Subject's Average Mean Gradient Measurements | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | Baseline, discharge, 3 months, and 1 year |
| Subject's Average Peak Gradients (mmHg) Measurements Over Time | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. | Baseline, discharge, 3 months, and 1 year |
| Subject's Average Effective Orifice Area Measurements | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. | Baseline, discharge, 3 months, 1 year |
| Subject's Average Effective Orifice Area Index (EOAI) Measurements | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. | Baseline, Discharge, 3 months, 1 year |
| Subject's Average Performance Index Measurements | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. | Discharge, 3 Months, 1 Year |
| Subject's Average Left Ventricular Ejection Fraction (LVEF) | Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%. | Baseline, discharge, 3 months, 1 year |
| Subject's Amount of Aortic Valvular Regurgitation Over Time. | Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | Discharge, 3 months, 1 year |
| Subject's Amount of Paravalvular Leak Over Time. | Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. | Discharge, 3 months, 1 year |
| Subject's Average Cardiac Output Over Time | The amount of blood the heart pumps through the circulatory system in a minute. | Discharge, 3 months, 1 year |
| Subject's Average Cardiac Output Index | A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA). | Discharge, 3 Months, 1 Year |
| Subject's Average Left Ventricular End-Diastolic Dimension | The measurement of the heart's left ventricle at end diastole. | Baseline, Discharge, 3 Months, 1 Year |
| Subject's Average Left Ventricular End-Systolic Dimension | The measurement of the heart's left ventricle at end systole. | Baseline, Discharge, 3 Months, 1 Year |
| Left Ventricular End-diastolic Volume (LVEDV) | Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole. | Baseline, Discharge, 3 Months, 1 Year |
| Left Ventricular End-systolic Volume (LVESV) | Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole. | Baseline, Discharge, 3 Months, 1 Year |
| Percentage of Subjects With Early Adverse Events | Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100. | Events occurring within 30 days of procedure |
| Percentage of Late Adverse Events Divided by Late Patient Years | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Events occurring >= 31 days and up through 2 years post-implant |
| Sankt Pölten |
| 3100 |
| Austria |
| Klinisshe Abteiluing Für Herz-thoraxchirurgie | Vienna | 1090 | Austria |
| Aarhus Universitetshospital Skejby | Aarhus N | 8200 | Denmark |
| CHU Bocage Central Dijon | Dijon | 21074 | France |
| Hôpital Saint Joseph - Marseille | Marseille | 13285 | France |
| Centre Hospitalier de Mulhouse | Mulhouse | 68051 | France |
| Centre Cardiologique du Nord St Denis | Saint-Denis | 93200 | France |
| Herz- und Gefäß-Klinik GmbH Bad Neustadt | Bad Neustadt an der Saale | 97616 | Germany |
| Westdeutsches Herzcentrum Uniklinik Essen | Essen | 45147 | Germany |
| Klinikum Nürnberg Süd | Nürenberg | 90471 | Germany |
| Clinica Santa Maria | Bari | 70124 | Italy |
| S. Anna Hospital | Catanzaro | 88100 | Italy |
| G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation | Massa | 54100 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Ospedale Niguarda Ca' Granda | Milan | 20162 | Italy |
| Università Cattolica del Sacro Cuore Policlinico | Roma | 00168 | Italy |
| Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" | Udine | 33100 | Italy |
| Catharina Hospital Eindhoven | Eindhoven | 5623 | Netherlands |
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Universitario Cruces Barakaldo | Barakaldo | 48903 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Universitätsklinik Für Herz und Gefässchirurgie | Bern | 3010 | Switzerland |
| Cardiocentro Ticino | Lugano | 6903 | Switzerland |
| Universität Zurich | Zurich | 8091 | Switzerland |
| St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Enrolled Cohort (Intent to Treat) |
|
| INTUITY (Study Valve Cohort) |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Cohort | Subjects were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The number analyzed is the number of patients with available data for the given parameter. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | The number analyzed is the number of patients with available data for the given parameter. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | The number analyzed is the number of patients with available data for the given parameter. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject's Average Time Spent on Cardiopulmonary Cross Clamp | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Mean | Standard Deviation | minutes | At time of surgery; an average of 1 hour |
|
|
| |||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Time Spent on Cardiopulmonary Bypass | Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Mean | Standard Deviation | minutes | At time of surgery; an average of 1.5 hours |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Skin-to-skin Time | The time from start of skin incision to end of skin closure. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Mean | Standard Deviation | Minutes | At time of surgery; an average of 3.5 hours |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Subject's Device Technical Success | Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place. | The outcome is reported for subjects where data is available. | Posted | Count of Participants | Participants | At time of surgery |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Health Care Utilization | The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure. | The outcome is reported for subjects where data is available. | Posted | Mean | Standard Deviation | Days | Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively. |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Count of Participants | Participants | 30 days, 3 months, 1 year, 2 years |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Mean Gradient Measurements | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Mean | Standard Deviation | mmHg | Baseline, discharge, 3 months, and 1 year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Peak Gradients (mmHg) Measurements Over Time | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Mean | Standard Deviation | mmHg | Baseline, discharge, 3 months, and 1 year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Effective Orifice Area Measurements | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | Centimeters squared | Baseline, discharge, 3 months, 1 year |
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| Other Pre-specified | Subject's Average Effective Orifice Area Index (EOAI) Measurements | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | centimeters squared/meters squared | Baseline, Discharge, 3 months, 1 year |
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| Other Pre-specified | Subject's Average Performance Index Measurements | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | cm^2/cm^2 | Discharge, 3 Months, 1 Year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Left Ventricular Ejection Fraction (LVEF) | Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Mean | Standard Deviation | Percentage of blood | Baseline, discharge, 3 months, 1 year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Amount of Aortic Valvular Regurgitation Over Time. | Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Count of Participants | Participants | Discharge, 3 months, 1 year |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Subject's Amount of Paravalvular Leak Over Time. | Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Count of Participants | Participants | Discharge, 3 months, 1 year |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Cardiac Output Over Time | The amount of blood the heart pumps through the circulatory system in a minute. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | liters per minute | Discharge, 3 months, 1 year |
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| Other Pre-specified | Subject's Average Cardiac Output Index | A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA). | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | L/min/m2 | Discharge, 3 Months, 1 Year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Left Ventricular End-Diastolic Dimension | The measurement of the heart's left ventricle at end diastole. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | centimeters | Baseline, Discharge, 3 Months, 1 Year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Left Ventricular End-Systolic Dimension | The measurement of the heart's left ventricle at end systole. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | centimeters | Baseline, Discharge, 3 Months, 1 Year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Left Ventricular End-diastolic Volume (LVEDV) | Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Deviation | milliliters | Baseline, Discharge, 3 Months, 1 Year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Left Ventricular End-systolic Volume (LVESV) | Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available. | Posted | Mean | Standard Error | milliliters | Baseline, Discharge, 3 Months, 1 Year |
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Subjects With Early Adverse Events | Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100. | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Number | Percentage of subjects | Events occurring within 30 days of procedure |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Late Adverse Events Divided by Late Patient Years | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available. | Posted | Number | Percentage of events/late patient years | Events occurring >= 31 days and up through 2 years post-implant |
|
|
Events occurring from baseline through two (2) years post implant
Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Cohort | Subject's were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon places the first guiding suture on the bioprosthesis. | 46 | 516 | 245 | 516 | 157 | 516 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic Reaction | General disorders | Systematic Assessment |
| ||
| Anemia - Bleeding related - Major | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia - Bleeding related - Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia - Non-bleeding related | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina, Stable | Cardiac disorders | Systematic Assessment |
| ||
| Angina, Unstable | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - AV Block - 1st degree | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - AV Block - 2nd degree | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - AV Block - 3rd degree | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Bundle Branch Block - Left | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Other | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Permanent Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Persistant Atrial Fibrillaiton | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Tachycardia - Ventricular | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Biliary (Gallbladder) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bleeding - Cardiovascular - Major | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Cardiovascular - Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Gastrointestinal upper -Major | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Gastrointestinal upper -Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Neurological - Major (e.g. CVA) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood/ Lymphatic - Other | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bone Fracture/Break | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cancer - Newly diagnosed | General disorders | Systematic Assessment |
| ||
| Cancer - Progression of underlying disease | General disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Decompensation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
| ||
| Cardiovascular - Other | Cardiac disorders | Systematic Assessment |
| ||
| Endocarditis | Cardiac disorders | Systematic Assessment |
| ||
| Gastrointestinal - Infection | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal - Other | Gastrointestinal disorders | Systematic Assessment |
| ||
| Genitourinary - Other | Renal and urinary disorders | Systematic Assessment |
| ||
| Heart Failure - Acute | Cardiac disorders | Systematic Assessment |
| ||
| Heart Failure - Chronic (CHF) | Cardiac disorders | Systematic Assessment |
| ||
| Hepatic complication - Other | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypertension - Systemic | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Infection /Inflammation - Other | Infections and infestations | Systematic Assessment |
| ||
| Liver Failure - Acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Multi-System organ failure | General disorders | Systematic Assessment |
| ||
| Muscular Skeletal / Dermatologic - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| NSD - Paravalvular Leak - +2 | General disorders | Systematic Assessment |
| ||
| NSD - Paravalvular Leak - +3 | General disorders | Systematic Assessment |
| ||
| NSD - Paravalvular Leak - +4 | General disorders | Systematic Assessment |
| ||
| Nonspecific, Unknown, or Other Body System - Other complication | General disorders | Systematic Assessment |
| ||
| Pancreatic complication | Gastrointestinal disorders | Systematic Assessment |
| ||
| Perforation - Atrial | Cardiac disorders | Systematic Assessment |
| ||
| Perforation - Other | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion - Major | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion - Minor | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Tamponade - Major | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion - Bilateral | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion - Left | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion - Right | Cardiac disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Psychiatric - Other | Psychiatric disorders | Systematic Assessment |
| ||
| Psychiatric Disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Embolism - Bilateral | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Embolism - Right | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary/Respiratory - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Regurgitation - Aortic-Central/Transvalvular-+3 | Cardiac disorders | Systematic Assessment |
| ||
| Regurgitation - Aortic-Central/Transvalvular-+4 | Cardiac disorders | Systematic Assessment |
| ||
| Regurgitation - Aortic-Indeterminate-+2 | Cardiac disorders | Systematic Assessment |
| ||
| Regurgitation - Aortic-Indeterminate-+4 | Cardiac disorders | Systematic Assessment |
| ||
| Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Failure - Acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Failure - Chronic | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Dysfunction/Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure -COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure -Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure -Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure -Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Infection - Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Infection - Upper (URI) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SVD - Stent frame separation | Product Issues | Systematic Assessment |
| ||
| Speech disorder | General disorders | Systematic Assessment |
| ||
| Sternal Wound/Thoracic Infection | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Suicide | Psychiatric disorders | Systematic Assessment |
| ||
| Thromboembolic Event - Other - Central - Hemiparesis | Cardiac disorders | Systematic Assessment |
| ||
| Thromboembolic Event - Other - Peripheral - No paresis | Cardiac disorders | Systematic Assessment |
| ||
| Thromboembolic Event - Stroke | Cardiac disorders | Systematic Assessment |
| ||
| Thromboembolic Event - Transient Ischemic Attack (TIA) | Cardiac disorders | Systematic Assessment |
| ||
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment |
| ||
| Valve Thrombosis - Aortic | Cardiac disorders | Systematic Assessment |
| ||
| Vascular - Other | Vascular disorders | Systematic Assessment |
| ||
| NSD - Paravalvular leak with Hemolysis | General disorders | Systematic Assessment |
| ||
| Respiratory Failure -Acute Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction - Medication related | General disorders | Systematic Assessment |
| ||
| Anemia - Bleeding related - Major | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia - Bleeding related - Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia - Non-bleeding related | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina, Stable | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - AV Block - 1st degree | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - AV Block - 3rd degree | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Bundle Branch Block - Left | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Bundle Branch Block - Right | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Permanent Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Persistant Atrial Fibrillaiton | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia - Tachycardia - Ventricular | Cardiac disorders | Systematic Assessment |
| ||
| Biliary (Gallbladder) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bleeding - Cardiovascular - Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Gastrointestinal lower -Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Gastrointestinal upper -Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Genitourinary - Minor | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood/ Lymphatic - Other | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bone Fracture/Break | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cancer - Newly diagnosed | General disorders | Systematic Assessment |
| ||
| Cardiovascular - Other | Cardiac disorders | Systematic Assessment |
| ||
| Endocrine complications | Endocrine disorders | Systematic Assessment |
| ||
| Gastrointestinal - Other | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heart Failure - Chronic (CHF) | Cardiac disorders | Systematic Assessment |
| ||
| Hepatic complication - Other | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypertension - Systemic | Cardiac disorders | Systematic Assessment |
| ||
| Infection /Inflammation - Other | Infections and infestations | Systematic Assessment |
| ||
| Muscular Skeletal / Dermatologic - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NSD - Paravalvular Leak - +2 | General disorders | Systematic Assessment |
| ||
| NSD - Paravalvular leak with Hemolysis | General disorders | Systematic Assessment |
| ||
| Nonspecific, Unknown, or Other Body System - Other complication | General disorders | Systematic Assessment |
| ||
| Pericardial Effusion - Minor | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion - Bilateral | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural Effusion - Left | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Psychiatric - Other | Psychiatric disorders | Systematic Assessment |
| ||
| Psychiatric Disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Pulmonary/Respiratory - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Failure - Acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Dysfunction/Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure -COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Infection - Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Infection - Upper (URI) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sternal Wound/Thoracic Infection | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Thrombocytopenia - Non-Heparin Induced | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thromboembolic Event - Other - Peripheral - Hemiparesis | Cardiac disorders | Systematic Assessment |
| ||
| Thromboembolic Event - Stroke | Cardiac disorders | Systematic Assessment |
| ||
| Thromboembolic Event - Transient Ischemic Attack (TIA) | Cardiac disorders | Systematic Assessment |
| ||
| Transient Psychotic Syndrome | Psychiatric disorders | Systematic Assessment |
| ||
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment |
| ||
| Vascular - Deep Vein Thrombosis (DVT) | Vascular disorders | Systematic Assessment |
| ||
| Vascular - Other | Vascular disorders | Systematic Assessment |
| ||
| Vision disorder | Eye disorders | Systematic Assessment |
| ||
| Wound Infection - Other | Infections and infestations | Systematic Assessment |
|
Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart | Edwards Lifesciences, LLC | 949-250-2500 | 0225 | Andrey_Nersesov@edwards.com |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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|
The study valve cohort consists of all patients that left the operating room with the study valve in place.
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
The study valve cohort consists of all patients that left the operating room with the study valve in place.
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
The study valve cohort consists of all patients that left the operating room with the study valve in place.
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
| OG003 |
| INTUITY (Study Valve Cohort) - 25mm |
The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
| OG003 | INTUITY (Study Valve Cohort) - 25mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
The study valve cohort consists of all patients that left the operating room with the study valve in place.
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
|
The study valve cohort consists of all patients that left the operating room with the study valve in place.
| OG004 | INTUITY (Study Valve Cohort) - 27mm | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
| OG005 | INTUITY (Study Valve Cohort) - Overall | The study valve cohort consists of all patients that left the operating room with the study valve in place. |
|
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| +1 Trivial/Trace |
|
| +2 Mild |
|
| +3 Moderate |
|
| +4 Severe |
|
|
|
| +1 Trivial/Trace |
|
| +2 Mild |
|
| +3 Moderate |
|
| +4 Severe |
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